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IRIS: Pioglitazone prevents secondary CV events in high-risk patients
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Nondiabetic, insulin-resistant patients at elevated risk for stroke or MI derive a greater benefit from pioglitazone compared with those at lower risk, but fracture risk is also higher, according to a secondary analysis of data from the IRIS trial.
Walter N. Kernan, MD, professor of medicine at Yale School of Medicine, and colleagues enrolled 3,876 participants (mean age, 63 years) with qualifying ischemic stroke or transient ischemic attack within 180 days of entry with insulin resistance but without type 1 or type 2 diabetes from February 2005 to January 2013.
Pioglitazone (Actos, Takeda) or placebo were randomly assigned for secondary prevention.
These results were originally presented at the International Stroke Conference 2016.
“In 2016, a study reported that the insulin sensitizer pioglitazone hydrochloride, when added to standard secondary prevention therapies, reduces the risk for stroke or myocardial infarction by an additional 24%,” Kernan and colleagues wrote. “Although it is generally well tolerated, pioglitazone is associated with weight gain, peripheral edema, and increased risk of bone fracture. Before prescribing pioglitazone, clinicians are advised to carefully weight its benefits and risks for individual patients.”
In the secondary analysis, the researchers assessed whether those at increased risk for stroke or MI benefited more from pioglitazone.
The researchers stratified the patients into two groups: above and below the median stroke risk.
Among those with lower risk, the 5-year risk for stroke or MI was 6% in the pioglitazone group vs. 7.9% in the placebo group (absolute risk difference, –1.9%; 95% CI, –4.4 to 0.6). In participants with higher risk, the 5-year risk for stroke or MI was 14.7% in the pioglitazone group vs. 19.6% in the placebo group (absolute risk difference, –4.9%; 95% CI, –8.6 to –1.2).
In patients below or above the median risk, the HRs were similar (0.77 vs. 0.75, respectively; P = .92).
Patients assigned pioglitazone at higher risk for MI or stroke gained less weight but were at increased risk for fracture vs. those with lower risk for MI or stroke.
“Our findings may help clinicians talk with patients who are considering pioglitazone therapy after ischemic stroke or TIA,” the researchers concluded. “In particular, clinicians can use these findings to more precisely estimate the likelihood for specific absolute benefits and harms, allowing patients to make informed decisions based on the person values they assign to prevention of vascular events vs. risk for adverse events.” by Cassie Homer
Disclosures: Kernan reports no relevant financial disclosures. One author reports she received a consultant fee from Takeda Pharmaceuticals. Another author reports he is a consultant for AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Lexicson, Janssen, Merck, Poxel, Sanofi and vTv Pharmaceuticals and serves on committees for Intarcia and Novo Nordisk.
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